ACTIVE_NOT_RECRUITING

Post-Market Clinical Follow-Up onTVT EXACT® Continence System

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Conditions

Stress Urinary IncontinenceGYNECARE TVT EXACT® Continence SystemSUI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

Official Title

A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence

Quick Facts

Study Start:2021-07-08
Study Completion:2036-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04829994

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Stress urinary incontinence symptoms
  2. 2. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
  3. 3. Female subjects ≥ 21 years of age requiring treatment of SUI
  4. 4. Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
  5. 5. Planned surgery for primary stress incontinence without concomitant prolapse surgery
  6. 6. Patient able and willing to participate in follow-up
  7. 7. Subject or authorized representative has signed the approved informed consent
  1. 1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires
  2. 2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
  3. 3. History of previous synthetic, biologic or fascial pubo-urethral sling
  4. 4. Pregnancy or plans for future pregnancy
  5. 5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
  6. 6. Current genitourinary fistula or urethral diverticulum
  7. 7. Reversible cause of incontinence (i.e. drug effect)
  8. 8. Contraindication to surgery

Contacts and Locations

Principal Investigator

Martin Weisberg, MD
STUDY_DIRECTOR
Ethicon, Inc.

Study Locations (Sites)

Duke University
Durham, North Carolina, 27707
United States
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, 19454
United States
UPMC
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Ethicon, Inc.

  • Martin Weisberg, MD, STUDY_DIRECTOR, Ethicon, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-08
Study Completion Date2036-02-28

Study Record Updates

Study Start Date2021-07-08
Study Completion Date2036-02-28

Terms related to this study

Keywords Provided by Researchers

  • GYNECARE TVT EXACT® Continence System
  • SUI

Additional Relevant MeSH Terms

  • Stress Urinary Incontinence